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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
RESPIRE MEDICAL HOLDINGS LLC
SPAT020US
In Commercial Distribution

  • 00851861007277 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
ACTIVATOR 9465AA PATIENT ACTIVATOR US
MEDTRONIC, INC.
9465AA
Not in Commercial Distribution

  • 00721902825569 ()


  • Cardiac pulse generator reader, home-use
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
TALLADIUM, INC.
5147-MLAT-D3
In Commercial Distribution

  • D7915147MLATD30 ()
5147-MLAT-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-D2
In Commercial Distribution

  • D7915147MLATD20 ()
5147-MLAT-D2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C3
In Commercial Distribution

  • D7915147MLATC30 ()
5147-MLAT-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C2
In Commercial Distribution

  • D7915147MLATC20 ()
5147-MLAT-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C1
In Commercial Distribution

  • D7915147MLATC10 ()
5147-MLAT-C1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-B2
In Commercial Distribution

  • D7915147MLATB20 ()
5147-MLAT-B2

  • Dental appliance fabrication material, ceramic
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